Cleared Traditional

K945569 - GCII AGAR WITH ISOVITALX(R) ENRICHMENT

K945569 is an FDA 510(k) clearance for GCII AGAR WITH ISOVITALX ENRICHMENT, manufactured by Becton Dickinson Microbiology Systems. The device is a Class 2 Microbiology device with product code JSO cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K945569 · Becton Dickinson Microbiology Systems · Microbiology device
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Optimized for regulatory review, auditing and printing
Feb 1995
Decision
114d
Days
Class 2
Risk

K945569 is an FDA 510(k) clearance for the GCII AGAR WITH ISOVITALX(R) ENRICHMENT. Classified as Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar (product code JSO), Class II - Special Controls.

Submitted by Becton Dickinson Microbiology Systems (Cockeysville, US). The FDA issued a Cleared decision on February 2, 1995 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1700 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Becton Dickinson Microbiology Systems devices

FDA 510(k) Submission Details - K945569

510(k) Number K945569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1994
Decision Date February 02, 1995
Days to Decision 114 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 102d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JSO Device Classification - Class 2, Special Controls

Product Code JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1700
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar

All 37
Devices cleared under the same product code (JSO) and FDA review panel - the closest regulatory comparables to K945569.
HAEMOPHILUS TEST MEDIUM AGAR (HTM)
K962744 · Prepared Media Laboratory, Inc. · Oct 1996
HAEMOPHILUS TEST MEDIUM (HTM)
K952595 · Clinical Standards Laboratories, Inc. · Apr 1996
CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST
K951754 · Hardy Diagnostics · Oct 1995
BRAIN HEART INFUSION AGAR
K944554 · Carr-Scarborough Microbiologicals, Inc. · Oct 1994
SYNERGY QUAD
K941443 · Remel Co. · Sep 1994
BHI AGAR WITH VANCOMYCIN
K941444 · Remel Co. · Sep 1994